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Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus

NCT ID: NCT02119039

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-12-31

Brief Summary

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CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies.

Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. Corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet A/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin.

The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. Results may lead to an improved management and pain reduction of patients with corneal epithelial defects.

Detailed Description

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Conditions

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Keratoconus

Keywords

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Cross-linking RGTA OTR4120 (CACICOL20)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RGTA OTR 4120 (CACICOL20)

Group Type EXPERIMENTAL

RGTA OTR 4120 (CACICOL20)

Intervention Type DEVICE

Genteal HA

Group Type ACTIVE_COMPARATOR

Genteal HA eye drops

Intervention Type DEVICE

Interventions

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RGTA OTR 4120 (CACICOL20)

Intervention Type DEVICE

Genteal HA eye drops

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women aged over 18 years
* Presence of keratoconus
* Scheduled for corneal cross linking
* No ophthalmic surgery in the 3 months preceding the study

Exclusion Criteria

* Participation in a clinical trial in the previous 3 weeks
* Topical use of aminoglycosid antibiotics
* Use of therapeutic or refractive contact lenses after surgery
* Known hypersensitivity to any component of the study medication or heparinoids or heparin
* Active ocular infection
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Katarzyna J. Witkowska

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Bata AM, Witkowska KJ, Wozniak PA, Fondi K, Schmidinger G, Pircher N, Szegedi S, Aranha Dos Santos V, Pantalon A, Werkmeister RM, Garhofer G, Schmetterer L, Schmidl D. Effect of a Matrix Therapy Agent on Corneal Epithelial Healing After Standard Collagen Cross-linking in Patients With Keratoconus: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1169-1176. doi: 10.1001/jamaophthalmol.2016.3019.

Reference Type DERIVED
PMID: 27584715 (View on PubMed)

Other Identifiers

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OPHT-070214

Identifier Type: -

Identifier Source: org_study_id